Therapeutic Goods Administration to adopt new version of the PIC/S Guide to Good Manufacturing Practice

23 November 2017

The Therapeutic Goods Administration (TGA) have advised the APVMA that from 1 January 2018, they will be adopting the latest version of the PIC/S Guide to Good Manufacturing Practice (GMP). 

The latest version, PIC/S Guide to Good Manufacturing Practice PE009-13 issued 1 January 2017 will be used for relevant inspections of veterinary chemical product manufacturers undertaken by the TGA. This includes inspections for the purposes of certification under the Mutual Recognition Agreement between the European Union and Australia, or for inspections of dual licence holders where the TGA inspections are recognised by the APVMA.

In preparation for the changes the TGA and APVMA are encouraging all manufacturer’s to:

  • Review the PIC/S Guide to Good Manufacturing Practice PE009-13, available from the PIC/S website and ensure you are familiar with the changes and requirements relevant to your manufacturing operations.
  • Commence preparations within your organisation in anticipation of PIC/S Guide to GMP PE009-13 being adopted.
  • Check the TGA website for regular updates on the adoption of the PIC/S Guide to GMP PE009-13.

All affected manufacturers are encouraged to review the information published by the TGA on their website

Manufacturers audited by APVMA authorised auditors for compliance with the Australian Code of Good Manufacturing Practice for veterinary chemical products will continue to be audited against this standard.

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